Catalog Number 0684-00-0567 |
Device Problem
Occlusion Within Device (1423)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) catheter therapy that the fiber optic cable stopped working immediately after insertion in the ccl.The radial arterial line was used for alternate as the central lumen was clotted.There was no injury or harm to the patient.
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Manufacturer Narrative
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09/08/2017 (b)(4): the product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering the rear portion of the balloon.One kink was found on the catheter tubing near the middle approximately 35.8cm from the iab tip.One kink was found on the catheter tubing near the y-fitting approximately 74.9cm from the iab tip.The optical fiber was found to be broken at this location.The technician attempted to flush/aspirate the inner lumen and was unable to do so.The technician then attempted to insert a 0.025¿ laboratory guide wire through the inner lumen and resistance was only felt at the kinked location near the y-fitting approximately 74.9cm from the iab tip.The optical fiber was found to be broken and the inner lumen and catheter tubing kinked, confirming the reported problems.The evaluation confirmed the reported problem.It is difficult to determine when or how a break in the fiber optic occurs.However, a kink in the catheter can cause the fiber optic to break resulting in no signal or the inability to calibrate it.A kink in the inner lumen can also cause poor or no pressure waveform and guide wire insertion difficulty.Blood may clot in the inner lumen during use if a continual flush is not maintained.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4); record # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) catheter therapy that the fiber optic cable stopped working immediately after insertion in the ccl.The radial arterial line was used for alternate as the central lumen was clotted.There was no injury or harm to the patient.
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Manufacturer Narrative
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(b)(4).Date received by manufacturer from 08/01/2017 to 09/06/2017 to reflect the most recent aware date.
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Event Description
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It was reported that during intra-aortic balloon (iab) catheter therapy that the fiber optic cable stopped working immediately after insertion in the ccl.The radial arterial line was used for alternate as the central lumen was clotted.There was no injury or harm to the patient.
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Search Alerts/Recalls
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